Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)

 Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.


Together with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), the Association of Indian Medical Device Industry (AIMED) has developed a voluntary quality certification scheme for medical devices in India, Indian Certification for Medical Devices (ICMED)

It is the country's first indigenously developed quality assurance system mandatory for all medical devices marketed in the nation. This was proposed in a recent meeting called for the drafting of (separate) rules for medical devices with government officials with a special focus on drafting regulatory framework for the granting of medical device manufacturing licenses.


The meeting discussed how to proceed with the registration of manufacturers and importers of medical devices on an online GoI portal. Most importantly, the meeting stressed the need for the registration of low-risk and moderate-risk devices based on certification by 3rd Party (CAB) and the granting of a manufacturing license to manufacturers and importers of high-risk devices based on specified criteria. This will be achieved by CDSCO medical devices officers with a predefined competency or by certification bodies of 3rd party according to sources.



Objective of certification;

➲ It is aimed at enhancing patient safety and provides enhanced customer protection.

➲ The scheme is intended to significantly eliminate the trading of sub-standard products or devices.

➲ Most significantly, it will reduce considerable time and costs for Indian companies to receive internationally recognized quality certification,


Benefits of certification


Benefits of registration

➲ Build brand trust of medical devices manufactured in India

➲ Enhance patient safety

➲ Provide healthcare users with quality medical devices manufactured in a certified facility

Who can apply for certification?

➲ Indian manufacturer or exporter

➲ Indian medical device importer/distributor


ICMED certification is of two type:


ICMED certification is of two types:

➲  ICMED 9000 (an ISO 9001plus additional requirement)

   This certification is for low-risk medical devices

➲  ICMED 13485 (an ISO 13485 plus additional requirement)

   This certification is for medium or high-risk devices.


Comments

Post a Comment

Popular posts from this blog

Steps for Registration of a Patent

  Step 1:     Idea or concept (Invention) must be written down with as many details as possible Step 2:   Drawings, diagrams or sketches explaining the working of the invention must be included while filing the application Step 3:  To check whether the invention is a patentable subject matter or not Step 4:  search for Patentability Step 5:  A patent application needs to be draft by applicant Step 6:  Publication of the application need to be done by the investor Step 7:  Examination request Step 8:  Respond to the objections raised Step 9:  objections must be cleared Step 10:  The final step is the grant of a patent to the inventor  Documents for Patent Registration ➲  Application in Form -1 which includes all the information related to name and address of inventor, name and address of applicant. ➲  Form-2 which describes the provisional or complete specification, as applicable along with the Drawings or sketches (if any) ➲  The Application form should also indicate clearly the source
Read more

Procedure for making registration under section 12A

Image
  ➲  Make application 10A On receipt of an application for the registration of a trust or institution, the Principal Commissioner or Commissioner shall request certain documentation or details from the trust or institution as he deems necessary to satisfy himself  the authenticity of the activity of the trust or institution; and  the compliance by the trustor institution of the provisions of any other law for the time being in effect for the purposes of fulfilling its purposes and may also make such inquiries as may be considered appropriate in that cases ➲  Granting of Certificate After being satisfied with the objects of the trust or institution and the authenticity of its operations and compliance with the criteria, he passes a written order registering the trust or institution, If he can not be so satisfied, he shall pass an order in writing refusing to register the trust or entity and a copy of that order shall be sent to the applicant. Please notice that no order shall be passed
Read more

Resignation or Removal of Director

  As per section 168 Resignation of Director A director may resign from his or her position by giving written notice to the Company; upon receipt of such notice, the Board shall take note of it; the Company shall notify the Registrar, and the Company shall include the fact of such resignation in the report of directors laid before the Company's next General Meeting. A director's resignation shall take effect on the day the notice is received by the company or if stated by the director in the notice, the date specified by the director in the notice, whichever is later. Even after his resignation, the resigned director is accountable for the offenses committed during his term. Call a Board of Directors meeting [as per section 173 and Secretarial Standard-1 (SS-1)] a. Upon receipt of the resignation letter, the Company shall send a Notice of Board Meeting to all of the Company's Directors at their registered addresses at least 7 days before to the Board Meeting. In the event o
Read more